Background and objectives Caregivers and clinicians of extremely preterm infants (born before 26 weeks’ gestation) depend on long-term follow-up research to inform clinical decision-making. The completeness of outcome reporting in this area is unknown. The objective of this study was to evaluate the reporting of outcome definitions, selection, measurement and analysis in existing cohort studies that report on neurodevelopmental outcomes of children born extremely preterm.
Methods We evaluated the completeness of reporting of ‘cognitive function’ and ‘cerebral palsy’ in prospective cohort studies summarised in a meta-analysis that assessed the effect of preterm birth on school-age neurodevelopment. Outcome reporting was evaluated using a checklist of 55 items addressing outcome selection, definition, measurement, analysis, presentation and interpretation. Reporting frequencies were calculated to identify strengths and deficiencies in outcome descriptions.
Results All 14 included studies reported ‘cognitive function’ as an outcome; nine reported both ‘cognitive function’ and ‘cerebral palsy’ as outcomes. Studies reported between 26% and 46% of the 55 outcome reporting items assessed; results were similar for ‘cognitive function’ and ‘cerebral palsy’ (on average 34% and 33% of items reported, respectively). Key methodological concepts often omitted included the reporting of masking of outcome assessors, methods used to handle missing data and stakeholder involvement in outcome selection.
Conclusions The reporting of neurodevelopmental outcomes in cohort studies of infants born extremely preterm is variable and often incomplete. This may affect stakeholders’ interpretation of study results, impair knowledge synthesis efforts and limit evidence-based decision-making for this population.
- outcomes research
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Contributors All authors are responsible for the reported research. All authors participated in the conception, design and drafting or revising of the manuscript. All approve the manuscript as submitted. All authors have different backgrounds and areas of expertise, uniquely contributing to this work. They meet authorship criteria as follows: SD codesigned the study, organised and carried out the training and scoring process, carried out the analyses, codrafted the initial manuscript and approved the final manuscript as submitted. EM codesigned the study, provided guidance for the training and scoring process, reviewed and revised the manuscript and approved the final manuscript as submitted. AC-A-T codesigned the study, organised and carried out the training and scoring process, reviewed and revised the manuscript and approved the final manuscript as submitted. MO codesigned the study, reviewed and revised the manuscript and approved the final manuscript as submitted. NB codesigned the study, reviewed and revised the manuscript and approved the final manuscript as submitted. GM conceptualised and codesigned the study, supervised the logistics of the study, codrafted the initial manuscript (without honorarium or financial gain) and approved the final manuscript as submitted.
Funding InsPECT development is funded by the Canadian Institutes of Health Research (Project #148953 to MO). This paper was funded by a Children’s Hospital of Eastern Ontario Research Institute 2018 Summer Studentship.
Competing interests None declared.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information. The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
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